ClinicalTrials.gg
RecruitingNCT07249788REZMASHUpdated Dec 3, 2025

Resmiterom Efficacy & Safety in Patients With MASH

A Phase 4 interventional study of Resmetirom in MASH - Metabolic Dysfunction-Associated Steatohepatitis, sponsored by Nabiqasim Industries (Pvt) Ltd. Recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-03.

Sponsored by Nabiqasim Industries (Pvt) Ltd · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year later.
Phase
Phase 4
Study type
Interventional
Enrollment
165
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Phase 4 clinical trial study aims to further evaluate the safety and therapeutic efficacy of Resmetirom in Pakistani patients with fibroscan proven MASH.

02

Conditions studied

  • MASH - Metabolic Dysfunction-Associated Steatohepatitis

Browse trials for

Keywords

  • Resmetirom
  • MASH
  • Safety
  • Efficacy
03

In context

Fatty Liver

663 studies on the registry are indexed under Fatty Liver; 185 are open to participants now.

This study's planned enrollment of 165 is above the median of 60 across 432 interventional studies indexed under Fatty Liver.

Browse Fatty Liver studies →

Lead sponsor

Nabiqasim Industries (Pvt) Ltd is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    • At least one metabolic comorbidity (e.g., T2DM, obesity, dyslipidemia and hypertension)

      • Clinical diagnosis of MASH using:

        • LSM ≥ 8.5kpa And/or
        • FAST score ≥0.67 And/or
        • FibroScan CAP ≥ 275 dB/m And/or
        • FIB-4 > 1.3

Exclusion criteria

Exclusion Criteria:

    • History of drug addiction and alcoholism

      • Cirrhosis or decompensated liver disease
      • Chronic viral hepatitis , )
      • MACE including MI, Stroke, PE etc.
      • Pregnant/lactating women
      • Concurrent use of other drugs
      • History of other liver diseases (viral, , drug-induced, alcohol)
      • Previous use of resmetirom in last 6 months
      • Significant renal impairment ( \<30)
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
165 participants (estimated)

Study arms

  • Experimental
    MASH targeted therapy

    MASH fibrosis stage 2 or 3

    Drug: Resmetirom

Interventions

06

What researchers measure

Primary outcomes

  1. FIB-4 and CAP score/LSM on fibroscan

    Changes in liver fibrosis using non invasive markers

    Time frame: 6 months

  2. Changes in thyroid profile

    thyroid profile of each patient at baseline and at primary end point

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Liver transplant center, Holy family hospital
    Rawalpindi, Punjab Province, Pakistan
    Recruiting
    • Shanila Akhter · Contact'shanilaakhter105@gmail.com' · +92 307 6738460
    • Dr Anum Shakeel · Contact
    • Dr. Muhammad Umar · Principal investigator
    • Dr Anum Shakeel · Principal investigator
    • Dr. Bushra Khar · Sub investigator
    • Dr Sadia Khan · Sub investigator
    • Dr Tayyab Sb. · Sub investigator
08

References and documents

Publications

  • Patel RH, Parikh C, Upadhyay H, Sonaiya S, Ramnath P, Singh S, Patel U, Kothari T. Resmetirom in the Management of Metabolic Dysfunction-Associated Steatohepatitis (MASH): A Comprehensive Review of Current Evidence and Therapeutic Potential. Cureus. 2024 Nov 29;16(11):e74772. doi: 10.7759/cureus.74772. eCollection 2024 Nov. PubMed 39735033 ↗
  • Younossi ZM, Stepanova M, Taub RA, Barbone JM, Harrison SA. Hepatic Fat Reduction Due to Resmetirom in Patients With Nonalcoholic Steatohepatitis Is Associated With Improvement of Quality of Life. Clin Gastroenterol Hepatol. 2022 Jun;20(6):1354-1361.e7. doi: 10.1016/j.cgh.2021.07.039. Epub 2021 Jul 27. PubMed 34329774 ↗
  • Harrison SA, Bashir MR, Guy CD, Zhou R, Moylan CA, Frias JP, Alkhouri N, Bansal MB, Baum S, Neuschwander-Tetri BA, Taub R, Moussa SE. Resmetirom (MGL-3196) for the treatment of non-alcoholic steatohepatitis: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2019 Nov 30;394(10213):2012-2024. doi: 10.1016/S0140-6736(19)32517-6. Epub 2019 Nov 11. PubMed 31727409 ↗
  • Harrison SA, Bedossa P, Guy CD, Schattenberg JM, Loomba R, Taub R, Labriola D, Moussa SE, Neff GW, Rinella ME, Anstee QM, Abdelmalek MF, Younossi Z, Baum SJ, Francque S, Charlton MR, Newsome PN, Lanthier N, Schiefke I, Mangia A, Pericas JM, Patil R, Sanyal AJ, Noureddin M, Bansal MB, Alkhouri N, Castera L, Rudraraju M, Ratziu V; MAESTRO-NASH Investigators. A Phase 3, Randomized, Controlled Trial of Resmetirom in NASH with Liver Fibrosis. N Engl J Med. 2024 Feb 8;390(6):497-509. doi: 10.1056/NEJMoa2309000. PubMed 38324483 ↗

Related links

Individual participant data

Plan to share: Undecided — Its undecided for now will be updated laterwards

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2025 (actual). Primary completion is estimated for Oct 2026, 11 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 18, 2025
First posted
Nov 25, 2025
StartActual
Oct 17, 2025
Primary completionEst.
Oct 16, 2026
CompletionEst.
Dec 31, 2026
Last update
Dec 3, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07249788
Lead sponsor
Nabiqasim Industries (Pvt) Ltd
Responsible party
Sponsor
First posted
Nov 25, 2025
Start date
Oct 17, 2025
Primary completion
Oct 16, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Dec 3, 2025

Study contacts

Hussain B Abidi, MBBS, MBA, CRCP
Contact
MDR.hussainabidi@gmail.com
+923322583236

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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